Suspension liner system with seal

ABSTRACT

A suspension liner is adapted to provide an interface between a residual limb and a prosthetic socket. The suspension liner defines an interior surface and an exterior surface forming a liner profile between a closed distal end and an open proximal end. The suspension liner defines a liner body portion formed from an elastomeric material and at least one seal protruding circumferentially about and radially outward a distance from the liner profile, which is defined at areas outside the at least one seal. The at least one seal has a distal root extending from the liner profile, a distal section projecting from the distal root and terminating at a peak defined as the outermost portion of the at least one seal, and a proximal section extending from the peak to a proximal free end arranged for deflection relative to the liner profile.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/978,770, filed Dec. 22, 2015, now U.S. Pat. No. 10,342,682 issuedJul. 9, 2019, which is a continuation of U.S. patent application Ser.No. 14/281,424, filed May 19, 2014, now U.S. Pat. No. 9,295,567 issuedMar. 29, 2016, which is a continuation of U.S. patent application Ser.No. 13/765,127, filed Feb. 12, 2013, now U.S. Pat. No. 9,056,022 issuedon Jun. 16, 2015, which is a continuation of U.S. patent applicationSer. No. 13/179,896, filed Jul. 11, 2011, now U.S. Pat. No. 8,894,719issued on Nov. 25, 2014, which is a continuation of U.S. patentapplication Ser. No. 11/654,549, filed Jan. 18, 2007, now U.S. Pat. No.8,034,120 issued on Oct. 11, 2011, which is a continuation of U.S.patent application Ser. No. 11/516,500, filed Sep. 7, 2006, now U.S.Pat. No. 7,909,884 issued on Mar. 22, 2011, which is a continuation ofU.S. patent application Ser. No. 11/135,354, filed May 24, 2005, nowU.S. Pat. No. 7,749,281 issued on Jul. 6, 2010, which is a continuationof U.S. patent application Ser. No. 10/690,545, filed Oct. 23, 2003, nowU.S. Pat. No. 7,025,793 issued on Apr. 11, 2006, which claims thebenefit of U.S. provisional application 60/434,669, filed Dec. 20, 2002.

BACKGROUND a. Field of the Invention

This invention relates to suspension liner sleeves adapted to provide aninterface between a residual limb and a prosthetic socket.

b. Discussion of Related Art

The use of suspension liner sleeves adapted to provide a soft, flexibleinterface between a residual limb of an amputee and a hard socket towhich a prosthetic device is secured is known in the art generally, asexemplified by U.S. Pat. No. 4,923,474 granted May 8, 1990 to Klassonand Kristinsson. Such liner sleeves are typically made of an airimpermeable elastomer material such as silicone and may include areinforcement layer intermediate the inner and outer surfaces of theliner sleeve body portion or externally thereof to provide resistanceagainst axial elongation of the elastomer constituting the liner sleevebody. Such reinforcement typically does not restrict radial distensionor stretching of the liner sleeve body.

In accordance with prior art teachings, such liner sleeves, sometimescalled suspension sleeves, may function to secure the residual limbwithin the prosthetic socket member once the residual limb and sleeveare inserted into the socket in close-fitting relationship by isolatingthe distal end area of the hard socket from the atmosphere. Uponapplication of a pulling force on the liner sleeve relative to thesocket, a suction is created in the distal end of the socket tending toretain the liner sleeve within the socket. Appropriate devices areusually provided to enable expulsion of air between the distal end ofthe liner sleeve and the hard socket, and to isolate the distal end ofthe hard socket member from the atmosphere after the liner sleeve with aresidual limb has been fully inserted within the socket member.

In some applications, the liner sleeve is provided with an umbrella atits distal end and a threaded socket for receiving a prosthetic securingpin member which then extends through an axial opening in the distal endof the hard socket member for securing the socket member relative to aprosthetic device mounted to the distal end of the socket member.

In other applications, the prosthetic device is secured to the exteriorof the distal end of the hard socket member and the sleeve member isfully contained within the hard socket member.

The elastomer constituting the liner sleeve member frictionally engagesand remains attached to the skin of a residual limb so that the limb isretained within the hard socket member in a comfortable, non-irritatingmanner. The liner sleeve may be thickened to provide cushioning effectbetween the residual limb and the hard socket, which is typically custommade to closely fit the residual limb. Liner sleeves of this kind areused for both trans-tibial (TT) amputees as well as trans-femoral (TF)amputees. That is, the liner sleeves may be utilized for applicationsabove the knee or below the knee of the amputee.

In other applications, it may be desired to more positively secure theliner sleeve within the socket by creating a hypobaric (vacuum) pressurewithin the distal end of the hard socket between such distal end and thedistal end of a liner sleeve inserted into the socket with a residuallimb contained within the liner sleeve. The hypobaric pressure may bemaintained at the distal end of the hard socket and the interior of thesocket at its distal end will be isolated from atmosphere during normalretention of the sleeve liner within the socket. Opening the distal endof the socket to atmosphere releases the vacuum or hypobaric pressurewithin the socket to enable simple withdrawal of a residual limb with aliner sleeve thereon from the socket.

A pump or other device may be utilized to evacuate the distal end of thesocket between the distal end of a liner sleeve and the distal end of asocket. A valve or other appropriate device typically is used to openand close the distal end of a socket to surrounding atmosphere.

Various arrangements are known in the prior art for providing anappropriate seal between the exterior of the liner sleeve and theinterior of the hard socket including external air impermeable sleevescovering the interface area between the proximal end of the hard socketand the adjacent liner sleeve body.

In trans-femoral applications, the sealing between a liner sleeve and asocket is generally simpler and easier to execute than sealing atrans-tibial liner sleeve against the inner surface of a socket becausein the latter situation, the residual limb contains more bonyprotuberances and irregular shapes that are difficult to effectivelyseal, particularly if it is desired to simply use the material of theelastomeric liner sleeve as the sealing element.

SUMMARY

In accordance with the present invention, an elastomeric liner sleevehaving an elongate, generally conical, air impermeable body portion thatis typically freely radially elastically distensible from a relaxednon-extended condition and including proximal and distal end areas isprovided with a resilient seal element protruding radially from a linersleeve body portion between its proximal and distal end areas, suchresilient seal element extending around an entire peripheral portion ofthe liner sleeve body portion.

In one embodiment, a suspension liner system adapted to provide aninterface between a residual limb and a prosthetic socket, the linersleeve including an elongate generally conical liner sleeve includingproximal and distal end areas, and a sealing member arranged toremovably fit onto the distal end area of the liner sleeve. The sealingmember has proximal and distal end areas, and defines a resilient sealelement located at the proximal end area and a receiving portion formedfrom the distal end area. The seal element outwardly protrudes relativeto the receiving portion of the liner sleeve and is arranged fordeflection against the liner sleeve.

According to variations of the embodiment, the liner sleeve may have arecessed portion extending around at least a peripheral portion of theliner sleeve to accommodate the seal element of the sealing member.Also, in another variation, the liner sleeve may be provided withreinforcement material that corresponds to the distal end area of theliner sleeve.

In other embodiments, the liner sleeve may include a plurality ofresilient seal elements that protrude radially from the liner bodyportion of the liner sleeve. These seal elements may be formedintegrally with the silicone inner layer of the liner sleeve, or may besecured to elastic matrix material of the liner sleeve.

In variations, the liner sleeve may include two different segments ofmatrix material, reinforcing material or covering material, wherein afirst material segment has greater stiffness than the second materialsegment. The plurality of seals may be disposed along the first materialsegment. The first and second material segments may be divided by acommon seam that varies in distance relative to the distal and proximalend areas of the liner sleeve to provide varying degrees of stiffness.

In use, a residual limb is placed within the liner sleeve body portionaccording to the invention and both the residual limb and the linersleeve body portion are inserted within a hard socket of a prostheticsystem so that the peripheral seal element engages an inner wall of thehard socket to isolate the distal end area of the hard socket fromsurrounding atmosphere. Creation of a hypobaric pressure within thedistal end area of the hard socket or simple evacuation or venting ofair between the distal end area of the liner sleeve body portion and thedistal end of the hard socket followed by sealing off the area betweenthe liner sleeve body portion and the internal distal end of the socketserves to effectively retain the liner sleeve within the socket of theprosthetic system, with the seal effectively isolating the distal end ofthe hard socket externally of the liner sleeve from atmosphere.

Whether a hypobaric pressure is created within the distal end area ofthe hard socket or if the distal end is merely isolated from atmosphere,withdrawal of the liner sleeve body portion and the residual limbcontained therein will be resisted strongly by the creation of ormaintenance of a suction between the distal end of the liner sleeve bodyportion and the interior distal end area of the hard socket when apulling force tending to extricate the liner sleeve body portion fromthe prosthetic socket is applied.

The suction may be released between the hard socket and the liner sleevesimply by exposing the interior distal end area of the hard socket toatmosphere.

The seal element serves to provide a positive sealing effect by itsresilient compression between the inner wall of the hard socket and theliner sleeve body portion due to the radial force of the residual limbwithin the liner sleeve body portion. The peripherally extending sealtakes up irregularities between the exterior of the liner sleeve and theinterior of the socket irrespective of bony protuberances,irregularities and non-cylindrical forms of the residual limb. Becausethe socket is already configured to closely approximate the exteriorshape of the residual limb, the seal simply follows the contour of theinner surface of the socket to isolate the distal end of the socket fromatmosphere when the liner sleeve is inserted into the socket.

In accordance with one embodiment, the liner sleeve includes anelongate, generally conical body portion formed from at least onematerial segment that is at least radially elastically extensible from arelaxed non-extended condition. The liner sleeve includes a plurality ofresilient seal elements that protrude radially from the liner bodyportion such that the plurality of seal elements extend around at leastone outer peripheral portion of the liner body portion.

In a variation of the embodiment, the seal elements are formed from apolymeric material secured to the at least one material segment. The atleast one material segment may include a first material segmentgenerally provided at the distal end area of the liner, and a secondmaterial segment secured to the first material segment. The firstmaterial segment preferably has stiffness greater than the stiffness ofthe second material segment. The second material segment may be securedto the first material segment along a seam varying in distance relativeto the distal and proximal end areas.

In a variation of the seal elements, the seal elements may each defineat least one curvilinear section extending from the liner body portionto a peak defined as the outermost extending portion of the sealelement. Alternatively, the seal elements each define a peak defined asthe outermost extending portion of the seal element, a distalcurvilinear section extending from the peak to the liner body portion,and a proximal curvilinear section extending from the peak to the linerbody portion. A pair of opposed annular recesses may be adjacentlylocated above and below each of the at least one seal element.

In another embodiment of the liner sleeve, the liner body portionincludes first and second layers of polymeric material disposed alongthe at least one material segment. The first layer of polymeric materialis secured directly to the at least one material segment and has agreater hardness than the second layer of polymeric material. Theplurality of seal elements may be formed from the second layer ofpolymeric material as it locally extends through the at least onematerial segment.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims, and accompanying drawings where:

FIG. 1 is a vertical sectional view of a prosthesis system including ahard socket, an elastomer liner sleeve having a reinforcement materialembedded in the liner sleeve body portion and further including aperipheral seal element integrated with the elastomer liner sleeve.

FIG. 2 is a sectional view corresponding to detail A in FIG. 1.

FIG. 3 is a cross-sectional view taken along line in FIG. 1.

FIGS. 4-10 are vertical sectional views of a prosthesis systemcorresponding to FIG. 1 wherein alternate forms of peripheral sealelements are illustrated.

FIGS. 11-16 are sectional views corresponding respectively with sectionsB, C, D, E, F, and G of FIGS. 4, 6, 7, 8, 9 and 10.

FIG. 17 is a vertical sectional view of an alternate form of anelastomer liner sleeve including a reinforcement material embedded inthe liner sleeve body portion and a peripheral seal element secured tothe elastomer liner sleeve in a recessed portion of the elastomer linersleeve.

FIG. 18 is a sectional view corresponding to detail H in FIG. 17.

FIG. 19 is a vertical sectional view of an alternate prosthesis systemincluding the liner sleeve of FIG. 17.

FIG. 20 is a sectional view corresponding to detail I in FIG. 19.

FIGS. 21-35 are vertical sectional views of alternate forms of theperipheral seal element illustrated in FIG. 17.

FIG. 36 is an elevational view of another embodiment of a prostheticliner.

FIG. 37 is an elevational view of an embodiment of an embodiment of asealing member.

FIG. 38 is a sectional view taken along line XXXVIII-XXXVIII in FIG. 37.

FIG. 39 is a vertical sectional view of an alternate prosthesis systemincluding the liner sleeve of FIG. 36.

FIG. 40 is a sectional view corresponding to detail J in FIG. 39.

FIG. 41 is a vertical sectional view of an alternate sealing member andprosthetic liner.

FIG. 42 is a sectional view corresponding to detail K in FIG. 41.

FIG. 43 is an elevational view of another embodiment of a prostheticliner.

FIG. 44 is a sectional view corresponding to detail L in FIG. 43.

FIG. 45 is an elevational view of another embodiment of a prostheticliner.

FIG. 46 is a sectional view corresponding to detail M in FIG. 45.

FIG. 47 is a sectional view taken along line XLVII in FIG. 45.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

With reference to FIG. 1, an elastomer liner sleeve body portion 1, forexample made of silicone, is formed as an elongate, generally conicalmember as is well known in the art and as is further described in U.S.Pat. No. 4,923,474, the entirety of which is incorporated herein byreference.

The liner sleeve body portion may be formed of various elastomermaterials that are known to those skilled in the art and that aretypically used for the manufacture of prosthetic liner sleeves.

The liner sleeve extends between a proximal end 2 and a distal end area3. The liner sleeve body portion is soft and at least radiallydistensible elastically. The liner sleeve also may be elasticallydistensible axially or may have limited axial elasticity or at least agreater elastic stiffness (resistance to distension) in an axial senseas compared with its radial elasticity, but such anisotropy is optional.

If it is desired to increase the axial stiffness of the liner sleevebody portion 1, a reinforcement material 4 is integrated into theelastomer of the liner sleeve body portion, for example in the mannerdescribed in U.S. Pat. No. 4,923,474. Various reinforcement materialsmay be utilized to limit axial distension of the liner sleeve bodyportion and typically a material that is axially stiff but radiallycompliant is preferred. Thus, the combination of the elastomer materialconstituting the liner sleeve body portion and the reinforcement bodymaterial results in a liner sleeve that resists elongation in the axialdirection in the event that tension is applied to the liner sleevematerial while the sleeve is fully radially compliant elastically so asnot to unduly compress a residual limb contained within the liner sleeveor restrict its ability to fill the hard socket member. Thereinforcement material 4 alternatively may be located externally of theelastomer, such as a textile cover on the elastomer liner sleeve body,for example.

The liner sleeve 1 is typically donned on a residual limb and the limband sleeve are then inserted into the prosthetic socket 5 which istypically rigid or hard in order to carry loads transferred from aprosthetic device attached to the socket to the residual limb andvice-versa.

The softer elastomer of the liner sleeve body portion adheres to theskin of a residual limb frictionally to thereby secure the limb withinthe sleeve. The liner sleeve, on the other hand, remains containedwithin the hard socket 5 after it has been fully inserted to the distalend area of the hard socket by effectively isolating the interior of thehard socket 5 from atmosphere.

Any pulling forces applied to the liner sleeve will result in a suctionbeing created between the distal end of the liner sleeve and theinterior of the hard socket at its distal end area. The increasedstiffness in an axial sense created by the reinforcement materialminimizes pumping action on the residual limb and creates a stifferinterface between the residual limb and the liner sleeve in the areaoccupied by the reinforcement material.

In accordance with the embodiment illustrated in FIG. 1, thereinforcement material 4 extends over a limited distal end area of theliner sleeve, but could extend fully around the distal end area of theliner sleeve, if desired, as shown, for example, in U.S. Pat. No.4,923,474, and up to the proximal end 2 of the liner sleeve.

To further enhance isolation of the distal end area of the hard socketfrom atmosphere, a seal element 6 associated with the liner sleeve isprovided. The seal element 6 could be formed of the same siliconematerial as the liner sleeve body portion 1 and created integrally inone piece with the liner sleeve body portion 1 during molding or formingof the liner sleeve body portion 1, or, alternatively, could be formedseparately of a softer or stiffer material or a material more suitablefor a seal than the material forming the liner sleeve body portion, andthen secured to the liner sleeve.

The seal element 6 may be tapered outwardly from its distal end towardsits proximal end to facilitate insertion of the liner sleeve bodyportion 1 into the hard socket 5 and tends to resist outward movement ofthe liner sleeve from the hard socket. Also, the form of seal element 6preferably provides an increased sealing force between the liner sleeve1 and the hard socket 5 when the liner sleeve 1 is moved in a directiontending to withdraw it from the hard socket, or in other words, the sealelement 6 seals more effectively in a direction towards the liner sleevedistal end when subjected to a pressure differential where a lowerpressure exists towards the distal side of the seal as compared to theproximal side thereof.

If desired, the seal element 6 could be formed as a separate element orassembly of elements attached to or otherwise secured to the linersleeve body portion 1, as will be described below. It will be apparentthat any manufacturing technique known to those skilled in the art couldbe utilized to create an enlarged seal element 6 surrounding theperipheral area of the liner sleeve body portion 1 at an area thereofbetween the proximal and distal end areas 2, 3 of the liner sleeve bodyportion 1 so that, upon insertion of the liner sleeve body portion intoa hard socket 5, the seal 6 isolates the distal end area of the interiorof the hard socket 5 from atmosphere between the seal 6 and the distalend area of the hard socket 5. While a single seal element may beutilized in accordance with the present invention, a plurality of sealrings 6 secured to the liner sleeve could be utilized to provideenhanced sealing effect, as will be described below.

When the liner sleeve body portion 1 is fully inserted into the socket5, the seal 6 fully isolates the interior of the socket distal end areafrom atmosphere until communication is provided between the interior ofthe socket distal end and atmosphere.

To permit purging of air from the distal end of the socket 5 while theliner sleeve body portion 1 and its associated seal 6 are inserted intothe socket, an appropriate one way valve element 7 may be provided, or avalve capable of opening and closing manually may be used to isolate theinterior of the distal end of the socket 5 from atmosphere.

It will be apparent that, when the liner sleeve body portion 1 is fullyinserted into the socket 5 with the seal 6 isolating the distal end areaof the socket 5 from atmosphere, all pulling loads tending to withdrawthe liner sleeve from the socket will result in a suction being createdbetween the distal end area of the liner sleeve 1 and the distal end ofthe socket 5. The seal 6 further enhances and maintains the suctionbetween the liner sleeve body portion 1 and the socket 5. The presenceof the reinforcement material in the vicinity of the seal 6 furtherenhances the function of the seal element 6 in maintaining the distalend area of the socket 5 isolated from atmosphere when the residual limband its associated liner sleeve body portion 1 have been fully insertedinto the socket due to better distribution of loads between the socket5, the liner sleeve body portion, and a residual limb.

If desired, a hypobaric pressure could be created between the distal endarea of the liner sleeve body portion 1 and the distal end of the socket5 by attaching a pump or other device that enables evacuation ofatmosphere between the seal 6 and the distal end of the socket 5.

With reference to FIGS. 4-16, various alternative preferred forms ofliner sleeve body portions, seal elements and hard socket interiorconfigurations are illustrated by way of example.

In FIG. 4, liner sleeve body portion 8 comprising an air-impermeableelastomeric material such as silicone is provided with a peripheral sealelement 9 shown in more detail in FIG. 11. The seal element 9 is formedas a separate element from the liner sleeve body portion 8 and issecurely attached thereto by appropriate bonding techniques that mayinclude adhesive, heat seal, etc. In this instance, the hard socket 5 ais provided with a slightly stepped portion 10 that enhances cooperationbetween the interior of the hard socket 5 a and the seal element 9. Thestepped portion 10 is not required but is optional. In this example, theseal element 9 includes a cantilevered end portion facing towards theproximal side of the liner sleeve body portion 8 to thereby enhance theability of the seal element 9 to freely flex when a pressuredifferential exists on either side of the seal element 9. It will beapparent that when a higher pressure exists on the proximal side of theseal element 9 as compared with the distal side thereof, the sealelement 9 will tend to expand outwardly against the interior surface ofthe hard socket 5 a and a radial sealing force exerted by the seal willincrease commensurately with the pressure differential. On the otherhand, the properties of the seal and the interior wall of the hardsocket 5 a are such that the amputee may readily withdraw the linersleeve body portion 8 from the hard socket 5 a upon gentle pulling ofthe liner sleeve away from the hard socket, optionally while openingvalve 7 to expose the isolated region 11 between the distal portion ofthe liner sleeve body portion 8 and the distal end area of the hardsocket 5 a to atmosphere.

In FIG. 5, liner sleeve body portion 12 is provided with multiple,axially spaced seal elements 9 a corresponding to seal element 9 in FIG.4. This provides enhanced sealing between the liner sleeve body portion12 and the interior of the hard socket 5 b due to the multiple sealingsurfaces provided and furthermore provides additional spaces 11 a thatare isolated from atmosphere to thereby enhance the suction effectbetween the liner sleeve body portion 12 and the hard socket 5 b. Thestepped portion 10 a of the hard socket interior wall is located at amore distal region of the hard socket as compared with the steppedportion 10 in FIG. 4.

In FIG. 6, liner sleeve body portion 13 is provided with a singleperipherally extending seal element 14 located towards the distal regionof the liner sleeve body portion 13. The seal element 14 is formedseparately from the liner sleeve body portion 13 and is secured theretoin the manner described above with respect to seal element 9 in FIG. 4.In accordance with this example, a reinforcement material 4 as describedabove in the example shown in FIG. 1 is provided to limit axialdistension of the liner sleeve body portion 13, the reinforcementmaterial being located in the vicinity of the seal element 14 andextending in a proximal direction relative thereto within the linersleeve body portion 13. The seal element 14 and its relationship withthe hard socket 5 c in this example, the liner sleeve body portion 13and the reinforcement material 4 are shown in more detail in FIG. 12.

In FIG. 7, liner sleeve body portion 15 is provided with a seal assembly16 which is shown in more detail in FIG. 13. In this example, the sleeveelement 16 may be formed as a strip of material having radially bendableflaps constituting seal surfaces that, when exposed to differentialpressure, will bend radially outwardly to engage the interior of thehard socket 5, which may correspond in shape to the hard socket 5illustrated in FIG. 1. The seal element 16 may be secured to the linersleeve body portion 15 by bonding, heat sealing, or any otherappropriate bonding technique that will be readily apparent to a personskilled in the art.

In FIG. 8, liner sleeve body portion 17 is provided with a peripheralseal element 16 which is similar to the seal element described in FIG.13, and a reinforcement material 4 is provided in the liner sleeve bodyportion 17 in a manner corresponding to that described previously withregard to FIG. 6.

In FIG. 9, liner sleeve body portion 18 is provided with an integralperipherally extending seal element 19 that is shown in more detail inFIG. 15. The seal element 19 is integrally formed in one piece with theliner sleeve body portion 18 and comprises multiple sealing surfacesinclined radially outwardly and upwardly as shown in FIG. 15. Eachradially outwardly extending element includes a sealing surface thatengages the interior wall of the hard socket 5 in a manner similar tothat described previously in connection with the seal elements 9, 9 a,15 and 16. That is, the form of the seal tends to increase sealingforces when the seal element is exposed to a pressure differentialbetween the proximal and distal sides of the seal element, with thehigher pressure existing towards the proximal end of the seal element.In this embodiment, a reinforcement material 4 is provided in the linersleeve body portion 18 in the vicinity of the peripheral seal 19 andextending proximally relative thereto.

In FIG. 10, liner sleeve body portion 20 is provided with a peripheralseal 21 corresponding to seal 19 described above in connection with FIG.9. A reinforcement material is not provided in this example. Theinterior of the hard socket 5 is not provided with a stepped portion inthis example, although a stepped portion corresponding to the steppedportion 10 could be provided at the distal end area of the seal 21 whenthe liner sleeve body portion 20 is fully inserted in the hard socket 5if desired.

With reference to FIGS. 17-20, an alternative preferred form of a linersleeve and seal element is illustrated.

In FIG. 17, liner sleeve body portion 22 having a proximal end 24 and adistal end area 26 is provided with a recessed portion 28 and aperipheral seal element 30 radially protruding from the recessed portion28. The recessed portion 28 extends continuously around a peripheralportion of the liner sleeve body portion 22 between the proximal anddistal end areas 24, 26. The recessed portion 28 of the liner sleevebody portion 22 is configured with a length, width and depth toaccommodate compression of the seal element 30. The liner sleeve bodyportion 22 may include a reinforcement material 32 that extendssubstantially around the distal area 26 of the liner sleeve body portion22 and preferably extends at least to the seal element 30. The placementof the reinforcement material 32 is not limited to the distal end areaof the liner sleeve body portion, and may extend upwardly to theproximal end 24 of the liner sleeve body portion 22.

As illustrated in FIG. 18, the seal element 30 of this embodiment isformed as a separate element from the liner sleeve body portion 22, andis provided with a base member 34 that is positioned within the recessedportion 28 and is securely attached to the liner sleeve body portion 22by appropriate bonding techniques that may include adhesive, heat seal,etc. The base member 34 is preferably parallel to the outer periphery ofthe liner sleeve body portion; however it will be understood that it isnot limited to this orientation. The seal element 30 includes a radiallyoutwardly pitched member 36 that extends from a proximal end of the basemember 34 and is directed towards the proximal end 24 of the linersleeve body portion 22 at an angle relative to the base member 34. Theseal element 30 also includes a radially inwardly pitched member 38 thatconnects to a proximal end of the outwardly pitched member 36, and isdirected towards the proximal end 24 of the liner sleeve body portion 22at an angle relative to the base member 34.

In FIG. 19, the liner sleeve body portion 22 is shown as being donned ona residual limb and the limb and liner sleeve body portion are insertedinto a prosthetic hard socket 40. Preferably, the hard socket 40includes a valve 7 located at a distal end area thereof that is of thetype described above in the preceding embodiments of the presentinvention. When inserted in the hard socket 40, the seal element 30 iscompressed so as to lie at least partially within the recessed portion28 and bridges a seal between the liner sleeve body portion 22 and thehard socket 40. In a compressed state, the angles at which the outwardlyand inwardly pitched members 36, 38 of the seal element 30 extendrelative to the base member 34 are substantially less than when theliner sleeve body portion 22 is not inserted into the hard socket 40.

It will be understood that when compressed, at least a portion of theseal element should radially distend at least a distance from therecessed portion to sufficiently bridge the seal between the linersleeve body portion and a hard socket.

As shown in FIG. 20, the recessed portion 28 may have a depth with adimension generally corresponding at least to the thickness of the basemember 34. Moreover, the length of the recessed portion may beconfigured so as to have a length that is less than the combined lengthof the base, outwardly and inwardly members so as to prevent the sealelement from becoming completely flat when the sleeve liner is insertedinto a hard socket.

With reference to FIGS. 21-35, alternative preferred forms of the sealelement shown in FIGS. 17-20 are illustrated. The alternative sealelements may be positioned within the recessed portion of the linersleeve body portion or along the exterior of the liner sleeve bodyportion.

As shown by example in FIGS. 21-27, a seal element 42 may have radiallypitched members having different lengths, thicknesses and widths,extending at different angles relative to the base member, or may beconnected to one another by a connecting member 44 generally parallelwith the base member. Moreover, the inwardly pitched member may includeat its proximal end an extension member 46 extending generally parallelwith the base portion detached from the liner sleeve body portion, or inthe alternative, may extend distally beyond the connection to theoutwardly pitched member. When extending beyond the outwardly pitchedmember, such distal portion 48 of the inwardly pitched member may have acurved, straight, or a combination of curved and straight profiles.Similarly, the outwardly pitched member may also extend proximallybeyond the connection to the inwardly pitched member and such proximalportion 50 thereof may have a curved, straight, or a combination ofcurved and straight profiles.

In another configuration of the seal element of the inventionillustrated in FIGS. 28-30, the radially outwardly and inwardly pitchedmembers may be replaced by a curved member 52 that extends from the basemember of the seal element. Said curved member may be defined asextending outwardly from the liner sleeve body portion to an apex andthen extending inwardly towards the liner sleeve body portion apredetermined distance. The inwardly extending portion of the curvedmember may extend a distance from the apex short of the outer peripheryof the liner sleeve body portion. Moreover, the curved member mayinclude at its proximal end an extension member 54 that is detached fromthe liner sleeve body portion and substantially parallel with the baseportion.

In yet another configuration of the seal element of the inventionillustrated in FIGS. 31-35, the seal element may include a taperedsegment 56 that extends proximally from the base member and under anoutwardly pitched member or curved member. Furthermore, in the event theinwardly pitched member or the proximal end of the curved member isconnected to an extension member 46 extending proximally therefrom, theextension member 46 may also include a tapered portion 56 distallyextending under an inwardly pitched member or curved member of the sealelement.

In another embodiment shown in FIGS. 36-40, a liner sleeve 110 isprovided which includes two main sections, proximal section 112, anddistal section 114. The proximal section 112 comprises a textile havingan inner surface that is coated with a silicone composition. The distalsection 114 comprises an outer surface that is a silicone composition.

According to one variation, the distal section consists of a siliconecomposition. In another variation, the distal section comprises atextile that is coated on both its inner and outer surfaces with asilicone composition. The outer surface of the distal section may besubstantially smooth, and may have an inherent tackiness.

As with other liner sleeve embodiments described herein, the linersleeve 110 may include a reinforcement material that is associated withthe liner sleeve and located over a length at least coinciding with thelocation of a sealing member 116 when fitted onto the liner sleeve 110.

Turning to FIGS. 37 and 38, the sealing member 116 is provided that isseparate from the liner sleeve 110. The sealing member 116 includes aseal element 118 provided at a proximal end area of the sealing member116. The sealing member 116 also includes a receiving portion 120located at the distal end area of the sealing member 116.

According to FIGS. 37 and 38, the seal element 118 may have inwardlypitched members 124, 126 which meet at peak 128 which forms a radiallyextending annular ring about the sealing member 116. The seal element118 may have any configuration shown in FIGS. 17-35.

As with the embodiment in FIG. 31, the seal element 118 of the sealingmember 116 may include a lip 122 extending from the receiving portiontowards the proximal end of the sealing member 116. According to thisvariation, the lip 122 is adapted to extend generally parallel to theouter wall of the liner sleeve 110.

The receiving portion 120 of the sealing member 116 is adapted tocorrespond to the shape of the distal end area of the liner sleeve 110.As shown in FIGS. 37-38, the receiving portion 120 is generallycup-shaped and spherical in nature, and the seal element 118 extendsradially outwardly relative to the outer wall of the receiving portion120. The receiving portion is not limited to a cup-shaped configurationand any suitable configuration that will correspond to a distal end areaof a liner sleeve may be used.

The sealing member 116 may be constructed from a variety of materials,such as polymers, rubbers, coated textiles and any other suitablematerial. According to the embodiment of FIGS. 36-39, the sealing member116 is constructed from a silicone composition such that along with thesilicone outer surface of the liner sleeve 110, the sealing member 116and the liner sleeve 110 will frictionally fit with one another due totheir inherent tackiness when they are contiguous. Moreover, as thesealing member 116 is fitted onto the distal end area of the linersleeve, air is expelled so as to enable the sealing member 116 to remainon the distal end area of the liner sleeve 110, and form an air-tightseal at portions corresponding to the receiving portion 120. The lip 122serves to divide the air-tight seal of the receiving portion 120 fromthe seal element 116, so the seal element 116 can form an air-tight sealbetween the hard socket 132 and the liner sleeve 110.

As shown in FIGS. 39 and 40, the liner sleeve 110 and the sealing member116 form part of a prosthesis system that further includes the hardsocket 132 having a one-way distal valve 134. Just as discussed above inreference to other embodiments, the combination of the liner sleeve 110and sealing member 116 conform to the shape of the internal socket wall,providing an airtight seal. When the liner sleeve 110 is fitted with thesealing member 116, and fitted in the socket, air is expelled throughthe distal valve 134, thereby creating hypobaric suction below the seal.The reinforcement material 130 of the liner sleeve 110 is provided toprevent elongation of tissue of the residual limb fitted with thesocket.

In another embodiment shown in FIGS. 41 and 42, the liner sleeve 136includes a recessed portion 138 that extends from a distal area of theliner sleeve to the distal end of the liner sleeve. The extent of therecessed portion 138 is governed by the size of the sealing member 116so that the seal element can be deflected into the recessed portion 138,and so that the receiving portion 120 forms an air-tight seal over therecessed portion 138 below the region in which the seal element 118 maybe deflected. The recessed portion 138 is reinforced with reinforcementmaterial 130 as in other embodiments described herein. In variations ofthis embodiment, the recessed portion 138 may merely comprise an annularrecess that does not form the entirety of the distal end area. Anexample of such a recessed portion may be found in the embodiment ofFIG. 17.

In accordance with another embodiment exemplified by FIGS. 43 and 44, aliner sleeve 210 includes an elongate, generally conical body portionformed from first and second material segments 212, 214 that are atleast radially elastically extensible from a relaxed non-extendedcondition and including proximal and distal end areas. The firstmaterial segment 212 may have stiffness greater than the stiffness ofthe second material segment 214. The liner sleeve 210 defines acontinuous profile 230 extending between the distal and proximal endareas. A distal reinforcing cup or umbrella 220 is provided at thedistal end of the liner 210.

The first and second material segments may be matrix material orreinforcing material, or a covering material described directly herein,described by way of the incorporated references, or known to thoseskilled in the art of liner sleeves.

The first and second material segments 212, 214 are secured to oneanother along a seam 218. The seam 218 may have a variety of shapes, andmay be configured to provide a gradual change relative to the distal andproximal end areas, as depicted in FIG. 43. The gradual change of theseam 218 may result in change in stiffness about the periphery of theliner sleeve by virtue of the different degrees of stiffness of thefirst and second material segments. Thus, by way of example, if theliner sleeve 210 is worn on a residual limb, the anterior side of theliner sleeve may have less overall stiffness than the posterior side dueto the seam on the anterior side being located closer to the distal endarea of the liner sleeve.

As with other embodiments described herein, a layer of a polymericmaterial, such as silicone, is provided on an inner surface of thesecond matrix material. As such, the polymeric layer defines the innersurface of the liner sleeve 210 whereas the second material segment maydefine the outer surface of the liner sleeve 210.

The polymeric layer may impregnate the first material segment 212 sothat the polymeric layer continuously defines the entirety of the innersurface of the liner sleeve. When the first material segment isimpregnated within the polymeric layer, the outer surface of the linersleeve at the region corresponding to the first material segment may bedefined by the polymeric layer, as in the embodiment of FIGS. 1-3. Invariations, the liner sleeve may be constructed in accordance with anyof the embodiments described herein.

The liner sleeve 210 includes a plurality of resilient seal elements 216protruding radially from the liner body portion along the first materialsegment 212. The plurality of seal elements 216 may extend eitherpartially or entirely around an outer peripheral portion of the firstmaterial segment 212.

Each of the seals 216 includes a root 222 extending from the linerprofile 230. An arcuate section 224 projects from the root 222 andterminates at a peak 226. A variable clearance 228 is defined betweenthe arcuate or curvilinear section 224 and the liner profile 230. Theseal 216 is arranged for deflection towards the liner profile 230 of theliner sleeve 210 when donned on a residual limb and placed within aprosthetic socket.

The plurality of seals 216 may be formed in accordance with any of theembodiments described herein. For example, they may be formed separatelyfrom the liner sleeve and secured thereto by suitable methods.Alternatively, the seals may be formed integrally with or molded fromthe polymeric layer. Further, the profile of the seals is not limited toarcuate or curvilinear forms, but may be substantially linear orcomprised of multiple linear segments.

In accordance with another embodiment exemplified by FIGS. 45-47 andsimilar to the embodiment of FIGS. 43 and 44, a liner sleeve 310includes an elongate, generally conical body portion formed from firstand second material segments 312, 314 that is at least radiallyelastically extensible from a relaxed non-extended condition andincluding proximal and distal end areas. The first and second materialsegments 312, 314 are secured to one another along a seam 326. The linersleeve 310 defines a continuous profile 324 extending between the distaland proximal end areas. A distal reinforcing cup or umbrella 313 isprovided at the distal end of the liner sleeve 310. The construction ofthe first and second material segments 312 and 314 may constructedsimilarly to those of FIGS. 43 and 44.

Unlike the embodiment of FIGS. 43 and 44, the first and second materialsegments 312, 314 both define the outer surface of the liner sleeve 310.

The liner sleeve 310 includes a plurality of resilient seal elements 316protruding radially from the first material segment 312 and beyond theliner profile 324. The plurality of seal elements 316 may extend eitherpartially or entirely around an outer peripheral portion of the firstmaterial segment 212.

Each of the seals 316 includes a distal root 318 extending from theliner profile 320. A distal arcuate section 320 projects from the distalroot 318 and terminates at a peak 322. A proximal arcuate section 321extends from the peak 322 to a proximal root 319. The seals 316 arearranged for deflection towards the liner profile 324 of the linersleeve 310 when donned on a residual limb and placed within a prostheticsocket.

A recess 330 is generally formed at both the distal and proximal roots318, 319. The recess 330 decreases friction at the roots 318, 319,against a hard, definitive socket when the liner 310 is worn incombination with the hard socket. The recess 330 provides a peel-offeffect when the liner is removed from the socket, wherein the recessesmay allow for a pistoning effect to break the seal of the liner againstthe socket.

It follows that the recess eliminates or minimizes shear forces existentbetween the socket and the liner, especially removal. Through theseattributes of the recesses, the recesses improve the durability of theseals and thus the liner by reducing wear on the seals themselvesdecreasing pressure points at the seal roots.

FIG. 47 specifically exemplifies the construction of the liner sleeve310 along the first material segment 312. The liner sleeve 310 may havea dual polymeric or silicone layer construction, such as differentsilicone layers 324, 326, as taught in U.S. Pat. No. 6,136,039, owned bythe assignee of this disclosure and incorporated herein by reference.The silicone layers 324, 326, each have a different hardness, whereinthe outer layer 326 is harder than the inner layer 324. The firstmaterial segment 312 is generally adhered to the outer layer 326. Atareas of the seals 316, a portion of the silicone of the outer layer 326extends through the first material segment 312.

The liner sleeve 310 of the embodiment of FIG. 45-47 may be constructedin accordance with the following method. First, the first and secondmaterial segments are sewn together along a common seam. The distalreinforcing cup is then molded onto the first material segment. The sewntogether first and second material segments are placed into a linermold, much in a same manner and using similar matrix materials as taughtin U.S. Pat. No. 6,485,776, commonly owned by the assignee of thisdisclosure and incorporated herein by reference. Unlike U.S. Pat. No.6,485,776, however, the liner mold includes a plurality of small annulargrooves corresponding to the plurality of seals 316.

As in U.S. Pat. No. 6,136,039, two types of silicone are injected intothe mold, with the first silicone having a higher hardness when curedthan the second silicone. Because the grooves in the molds arerelatively small, and the pressure in the mold is relatively high, thefirst silicone is squeezed through first material segment into thegrooves of the mold. It will be noted that whereas the first materialsegment is generally stiffer in nature than the second material segment,the first material segment is selected on the basis that it does notstretch into the grooves of the mold, thereby allowing only the firstsilicone to pass through the first material segment to form theplurality of seals.

The liner sleeve of any of the embodiments herein may be constructed inthe manner described above in reference to the embodiment of FIGS.45-47. Moreover, the liner sleeve is not limited to having two layers ofsilicone each having a different hardness, but may comprise a singlesilicone layer or multiple layers of silicone beyond just the twodescribed herein.

The liner sleeve is not limited to being formed at least in part fromsilicone. Other suitable polymeric materials for use in liner sleevesmay used, as explained in greater detail in U.S. Pat. Nos. 6,706,364 and6,964,688, both of which are incorporated herein by reference.

The embodiments of the liner sleeve described herein are not limited tobeing formed with corresponding matrix materials. Instead, they may bemade without any matrix materials, and solely with molded polymericmaterials. Additionally, a liner sleeve may be provided with at leastone covering or segments thereof which cover the outer portion of thepolymeric portions of the liner sleeve but do not necessarily serve as areinforcing material.

The embodiments of FIGS. 43-47 are advantageous in that they do notstrangle a residual limb on trans-tibial users since the plurality ofseals more evenly distribute traction than a single seal system. Itfollows that by providing multiple seals, the seal does not createlocalized pressure peaks on the residual limb. The strangling ofresidual limbs may occur at bony or sensitive areas of the residuallimb. Moreover, by virtue of the method for making liner of FIGS. 45-47,there is no need to adhere a seal to the liner which greatly simplifiesthe manufacturing and improves the durability of the liner.

It will be understood that the aforementioned embodiments of the presentinvention are not limited to the described combination of the linersleeve body portion, seal element and hard socket. Instead, the featuresof one of the preferred embodiments of the present invention may readilybe combined with those of another or other embodiments of the presentinvention without departing from the scope of the present invention.

It will be readily understood that the described embodiments of theinvention are exemplary only and various other features and detailscould be incorporated in the system described herein without departingfrom the spirit and scope of the invention as defined in the appendedclaims.

The invention claimed is:
 1. A suspension liner adapted to provide aninterface between a residual limb and a prosthetic socket, thesuspension liner defining an interior surface and an exterior surfaceforming a liner profile between a closed distal end and an open proximalend, the suspension liner comprising: a flexible elongate, generallyconical liner body portion formed from an elastomeric material; and atleast one seal protruding circumferentially about and radially outward adistance from the liner profile closer to the closed distal end than tothe open proximal end, the at least one seal having a base membersecured to the liner body portion, a radially outwardly pitched memberprojecting from the base member to a proximal end of the radiallyoutwardly pitched member defined as an outermost portion of the at leastone seal, and a radially inwardly pitched member extending from theproximal end of the radially outwardly pitched member to a free endarranged to face the liner profile when the at least one seal isuncompressed and to deflect along the liner profile when the at leastone seal is compressed between the prosthetic socket and the linerprofile; wherein the liner body portion defines a recessed portion thatis recessed with respect to the exterior surface defined continuouslyaround a peripheral portion of the liner body portion, the base memberpositioned within the recessed portion, said recessed portion having adepth generally corresponding to a thickness of the base member.
 2. Thesuspension liner of claim 1, wherein a variable clearance is definedbetween the free end of the at least one seal and the liner profile. 3.The suspension liner of claim 1, wherein the radially outwardly pitchedmember and the radially inwardly pitched member are cantilevered fromthe base member.
 4. The suspension liner of claim 1, wherein a variableclearance is defined between the radially outwardly pitched member ofthe at least one seal and the liner profile.
 5. The suspension liner ofclaim 1, wherein the at least one seal has a width between the radiallyoutwardly pitched member and the radially inwardly pitched member towardthe proximal end of the radially outwardly pitched member.
 6. Thesuspension liner of claim 1, wherein the radially outwardly pitchedmember extends radially outwardly and upwardly from the base member tothe proximal end of the radially outwardly pitched member.
 7. Thesuspension liner of claim 1, wherein the radially inwardly pitchedmember extends radially inwardly and upwardly from the proximal end ofthe radially outwardly pitched member.
 8. The suspension liner of claim1, wherein the radially inwardly pitched member and the radiallyoutwardly pitched member have a same thickness.
 9. The suspension linerof claim 1, wherein the at least one seal defines a sealing surfacearranged to take up a higher pressure when donned on the residual limband engaged with an interior wall of the prosthetic socket.
 10. Thesuspension liner of claim 1, wherein the proximal end of the radiallyoutwardly pitched member is arranged for deflection relative to theliner profile.
 11. The suspension liner of claim 1, wherein the linerbody portion includes a reinforcement material that is generally axiallystiff and radially compliant, the reinforcement material being differentfrom the elastomeric material.
 12. A prosthesis system comprising: aprosthetic socket adapted to a shape of a residual limb; and asuspension liner sleeve adapted to provide an interface between theresidual limb and the prosthetic socket, the suspension liner sleeveincluding: a flexible elongate, generally conical liner body portionformed from an elastomeric material, the body portion defining aninterior surface and an exterior surface forming a liner profile betweena distal end area and a proximal end area; and at least one sealprotruding circumferentially about and radially outward a distance fromthe liner profile closer to the distal end area than to the proximal endarea, the at least one seal having a base member secured to the linerbody portion, a radially outwardly pitched member distal sectionprojecting from the base member to a proximal end of the radiallyoutwardly pitched member defined as an outermost portion of the at leastone seal, a radially inwardly pitched member extending from the proximalend of the radially outwardly pitched member to a free end arranged toface the liner profile when the at least one seal is uncompressed and todeflect along the liner profile when the at least one seal is compressedbetween the prosthetic socket and the liner profile, and a variableclearance defined between the radially inwardly pitched member and theliner profile; wherein the liner body portion defines a recessed portionthat is recessed with respect to the exterior surface definedcontinuously around a peripheral portion of the liner body portion, thebase member positioned within the recessed portion, said recessedportion having a depth generally corresponding to a thickness of thebase member.
 13. The prosthesis system of claim 12, further comprisingan evacuation device arranged for evacuating air from between the distalend area of the body portion and a distal end of the prosthetic socket.14. The prosthesis system of claim 12, wherein the free end iscantilevered from the base member.